The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to provide comments in response to the Department of Health and Human Services’ (HHS’s) request for information on the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs [RIN 0991-ZA49] (Blueprint).
On July 13, 2018, AMCP provided comments in response to FDA Final Guidance on Payor- Manufacturer communications. AMCP supported the need for timelier and more proactive
communications between biopharmaceutical manufacturers and population health decision makers. AMCP applauded the FDA for its leadership and recognition of the importance of
modernizing the provisions of the Food and Drug Administration Modernization Act (FDAMA) Section 114 as amended by Section 3037 of the 21st Century Cures Act (Cures) and the creation of a safe harbor for the exchange of preapproval communications.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers [FDA-2016-D-1307]” as published in the Federal Register on June 13, 2018.
The Alliance wants to ensure an FDA that is sized and modernized to meet its mandate in the 21st century. The FDA oversees products that represent 20% of consumer spending in the US and affect every American multiple times each day. Its responsibilities are global in scope and form the backbone of the world’s economy.